Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00992160 | Vestipitant 28-day Tolerance Study | PHASE2 | COMPLETED | 161 | — | — | May 1, 2009 | Sep 1, 2009 | Oct 28, 2016 | 13 | Germany |
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | Vestipitant 15mg once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| GW597599 | DRUG | GW597599 15mg tablet |
| Placebo | DRUG | Placebo to match GW597599 15mg tablet |
Inclusion Criteria: * Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders -Text Revision (DSM-IV-TR) criteria 307.42 * PSG variables collected during 2consecutive PSG screening nights falling as follows: ...